Pediatric Project Manager II
6 days ago
The University of Utah is seeking a highly skilled Pediatric Project Manager II to join our team. As a key member of our research team, you will be responsible for managing clinical trials for pediatric patients, ensuring compliance with regulatory requirements, and collaborating with investigators and researchers to advance our understanding of pediatric health.
Responsibilities- Manage all aspects of study conduct, regulatory compliance, and record keeping processes at the site or institution level.
- Assure regulatory compliance for the data coordinating center.
- Maintain research data files and regulatory documents for all clinical trial sites.
- Identify and create queries to improve data capture and assist in developing methods to clarify/clean existing data.
- Review site monitoring reports and discuss findings with Study Investigators and offer suggestions and solutions to problems, concerns, or recurrent trends or themes.
- Assure that adverse events are reported to the sponsor.
- Review site records for accuracy regarding test article accountability (if applicable).
- Develop study specific network guidelines and Standard Operating Procedures.
- Organize study trainings and give presentations to employees and other research coordinators on good clinical practices and study procedure implementation.
- Act as liaison between study Investigators and sponsors to communicate and resolve issues.
- Assume considerable leadership responsibilities of studies throughout the network.
- Provide feedback on study site performance, compliance, and data quality.
- Make recommendations regarding site disciplinary actions, which may result in site monitoring visits, suspension, or discontinuation of a study site.
- Perform remote site monitoring activities independently.
- Bachelor's degree in a health science field, or equivalency.
- 4 years of clinical research experience that includes project management.
- Experience with human subjects research, good leadership skills, and working knowledge of FDA, ICH, and other regulatory compliance.
- Excellent interpersonal and communications skills, both oral and written.
- Proficient in Microsoft Office and possess the ability to learn new software programs such as electronic data capture software.
- Credentialing as a Certified Clinical Research Coordinator (CCRC), Certified Clinical Research Professional (CCRP), Certified Clinical Research Associate (CCRA), or other related certification.
- Experience in the specific clinical research area.
- Depending on the area of assignment, current medical licensure may be preferred.
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